Documentation Control Manager
Ximedica is an ISO 13485:2012 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, San Francisco, Silicon Valley and Hong Kong. We have an exclusive focus on medical products, and over 25 years of experience developing medical devices, combination products, and consumer healthcare products.
We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Position: The Documentation Control Manager leads and manages all aspects our Ximedica’s Document & Record Management systems in compliance with QSR/ISO 13485.
Nature of Role: The Documentation Control Manager is responsible for the overall management of the documentation control system for Ximedica. This includes supervision and execution of all Documentation Control activities, and personnel engaged in those activities, including the change control process, quality records archiving, etc. The position interfaces with other departments and teams to give guidance and direction to ensure that documentation complies with Ximedica standards and regulatory requirements.
- Provide management oversight and expertise in document and records management and quality records management systems.
- Manage the day-to-day engineering change control process and provide guidance and direction to company personnel on execution of changes.
- Manage and direct the activities of the Document Control department personnel.
- Responsible for oversight, alignment and execution of documents with internal operations and external sources to assure compliance with Quality System requirements.
- Develop, document and promote document control best practices.
- Own CAPAs, audit findings, and continual improvement activities as assigned by supervisor.
- Train staff on document control processes and procedures.
- Responsible for establishing and maintaining the global standards library.
- Document Control systems (i.e.- Agile, Trackwise, MasterControl, SolidWorks).
- Assist in the development and implementation of electronic Product Lifecycle Management (PLM), Product Data Management (PDM) and/or PDM, etc.).
- May own and manage the quality system software process.
- Other responsibilities as assigned by supervisor.
Requirements: Detail-oriented, energetic self-starter with strong communication and organizational skills. The successful candidate will have a proven ability to multi-task and work collaboratively as well as independently in a dynamic and entrepreneurial environment. The position requires a minimum of 5 years of experience in a documentation control role, and experience in management, in a Medical Device/Health Care organization. Additional qualifications are as follows:
- A Bachelor’s degree or equivalent experience in Documentation Control in a design, development and manufacturing environment. releases and versioning, naming conventions, record management, etc.)
- Thorough understanding of document control, configuration management and engineering change control processes (e.g., part numbering, ISO 13485, etc., including Part 11 compliance.
- Working understanding of the principles of Medical Device and healthcare regulations including FDA’s Quality System Regulation (QSR).
- Excellent organizational and time management skills. Detail oriented, dependable and willing to handle multiple priorities.
- Successful communication skills, business acumen and assertive decision-making ability.
- (PDM) and Document Control systems (i.e.- Agile, Trackwise, MasterControl, SolidWorks PDM, etc..).
- Experience with implementing (preferred), using, and managing electronic Product Lifecycle Management (PLM), Product Data Management.
- Preferred experience in software validation.
- Please note: JOB CODE #846 when applying.
Send resume to: [email protected].
EQUAL OPPORTUNITY EMPLOYERXimedica provides equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.